LDTs Rule Update: More Support for Legal Challenges Against FDA

The Association for Diagnostics & Laboratory Medicine (ADLM) has officially added its support to one of the lawsuits against the FDA regarding its laboratory-developed tests (LDTs) final rule. Though the association did not file its own legal challenge or join either of the two current lawsuits against the agency, ADLM filed an amicus brief in the American Clinical Laboratory Association (ACLA)’s case.

The brief, which was filed jointly with four other clinical laboratory societies on October 7, asks the court “to strike down the rule before it causes irreparable patient harm,” according to an ADLM statement. ADLM added that it supports the ACLA’s position that the FDA is overreaching its authority by regulating LDTs as medical devices. Another key point in the brief that many in the industry have previously argued is that laboratories are already highly regulated, and FDA oversight will only add another unnecessary layer of regulation.

“While we fully support FDA’s goal of making sure that laboratory-developed tests are safe and accurate, a much more effective way to achieve this goal would be to review and update CMS’s existing standards,” said ADLM president Anthony Killeen in the ADLM statement. “We look forward to the court’s resolution of this important case, and we hope that it will pave the way for a better solution to this issue.”

Key lab societies have also pointed out that the LDTs rule, though not yet in effect, is already having a negative impact on labs and patients.

“The FDA’s rule is already undermining the ability of clinical laboratories to develop and use LDTs and…this is negatively impacting patient care,” the American Society for Clinical Pathology, another of the organizations behind the amicus brief, stated in a September press release.

The American Association of Bioanalysts, Infectious Disease Society of America, and the American Society for Microbiology are the other societies behind the brief.

Strong support for ACLA’s position

Whether the brief will be considered is up to the court, however, given the anti-regulatory stance of the Texas court where the ACLA case was filed on May 29, the arguments included will likely be taken into consideration, adding to strong support for the case. A separate legal challenge to the FDA’s final rule by the Association for Molecular Pathology (AMP) was filed in August, and the two cases were consolidated by the courts in September.

A weakened FDA position?

In a recent decision that may weaken the FDA’s case, the U.S. Supreme Court overturned the Chevron doctrine in Loper Bright Enterprises v. Raimondo, which, according to a recent Lab Industry Advisor article by attorney Christine Bump, required courts to defer “to a federal agency’s reasonable interpretation of an ambiguous statute.” Overturning Chevron means that courts will now decide whether to agree or disagree with a government agency’s interpretation of unclear laws. This means that the FDA’s view that LDTs are medical devices—and that it therefore has the authority to regulate them—is now on shakier ground.

What does this mean for labs affected by the LDTs rule?

The recently added support for the legal challenges to the FDA’s LDTs rule may also increase uncertainty about whether the rule will go ahead. According to the final rule, affected labs are expected to comply with at least some FDA IVD regulations starting May 6, 2025.

However, even with the consolidation of the two lawsuits expected to speed up the legal process with both ACLA and AMP seeking a summary judgment, which would allow a decision on the case without a trial, the courts may not make a final decision until summer 2025, according to the College of American Pathologists.

This leaves affected labs in a tough position when it comes to complying with stage I of the FDA’s final rule. Labs must decide whether to spend the time, cost, and effort to comply or continue as usual and hope the rule is either delayed or abandoned completely.

Want more clarity around the FDA’s LDTs final rule? As part of our November Lab Institute Virtual Event, we’ll be hosting a panel of three regulatory experts to answer readers’ questions. Learn more here.

See our previous LDTs-related articles:

• FDA Proposal for LDTs Risks Serious Consequences

• 3 Thoughts on the FDA’s Final LDTs Rule

• LDTs Around the World

• New FDA LDTs Guidance Offers Useful Summary, But Questions Remain

• Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule

See our on-demand LDTs-related webinars:

• Key Things Labs Need to Know About the FDA’s Final LDTs Rule

• Oncology LDTs: How Cancer Labs Can Best Navigate the FDA’s Final Rule

• Loper Bright and the Potential Impact on the Laboratory Industry